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Last Updated: March 25, 2026

Details for New Drug Application (NDA): 216906


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NDA 216906 describes BRIMONIDINE TARTRATE, which is a drug marketed by Padagis Israel, Alembic, Apotex, Bausch And Lomb, Dr Reddys Labs Sa, Lupin Ltd, Micro Labs, Regcon Holdings, Rising, Sandoz, Somerset Theraps Llc, Teva Parenteral, Upsher Smith Labs, Amneal, Caplin, Glenmark Pharms Ltd, Sentiss, and Somerset, and is included in twenty-nine NDAs. It is available from eleven suppliers. Additional details are available on the BRIMONIDINE TARTRATE profile page.

The generic ingredient in BRIMONIDINE TARTRATE is brimonidine tartrate; timolol maleate. There are eleven drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the brimonidine tartrate; timolol maleate profile page.
Summary for 216906
Tradename:BRIMONIDINE TARTRATE
Applicant:Somerset Theraps Llc
Ingredient:brimonidine tartrate
Patents:0
Pharmacology for NDA: 216906
Mechanism of ActionAdrenergic alpha-Agonists
Medical Subject Heading (MeSH) Categories for 216906
Adrenergic alpha-2 Receptor Agonists
Antihypertensive Agents
Suppliers and Packaging for NDA: 216906
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BRIMONIDINE TARTRATE brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 216906 ANDA Somerset Therapeutics, LLC 70069-566 70069-566-01 1 BOTTLE in 1 CARTON (70069-566-01) / 5 mL in 1 BOTTLE
BRIMONIDINE TARTRATE brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 216906 ANDA Somerset Therapeutics, LLC 70069-567 70069-567-01 1 BOTTLE in 1 CARTON (70069-567-01) / 10 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.1%
Approval Date:Aug 9, 2024TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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